Catalog Number

30.35

Brand Name

Synergetics

Version/Model Number

30.35

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HMX

Product Code Name

Cannula, ophthalmic

Public Device Record Key

cf52f8f6-b388-4eb4-bd68-0e7b314769d7

Public Version Date

June 08, 2020

Public Version Number

1

DI Record Publish Date

May 30, 2020

Package DI Number

20841305111923

Quantity per Package

6

Contains DI Package

10841305111919

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box